Anecto tests to ISO 80369-7!

Do your Luer connectors comply with the new ISO 80369-7 requirements?

Anecto can help validate and challenge all luer types and we have a full offering of ISO 17025 accredited performance tests.
In line with Anecto’s constant development and dedication to be at the highest levels of conformance in medical device testing, we can now announce that we are accredited to test to ISO 80369-7 & ISO80369-20.

ISO 80369-7 is the new standard for luer fittings (small-bore connectors for liquids and gases in healthcare applications, specifically connectors for intravascular or hypodermic applications).

The new standard replaced the ISO 594-1/-2 standards this year and is currently on the books, with a transitionary period due to end on December 31 2019.

New requirements include:

Updated performance tests according to ISO80369-7/20:

Fluid Leakage

Sub-Atmospheric Pressure Air Leakage

Stress Cracking

Resistance to Separation from Axial Load

Resistance to Separation from Unscrewing

Resistance to Overriding

New dimensional tolerance verification

Injection moulding process validation

Accelerated ageing studies

Bespoke test design including over-torque, flow, high pressure and simulated use